Catheter insertion device with blood analyzer

ABSTRACT

A device and method yielding a blood analysis employable in combination with an introducer for a catheter for a concurrent testing of blood from the introducer flash chamber during placement of a venous catheter. The device employs a colorimetric blood analysis to provide the user a visually discernable alert to the results of tested blood concurrent with the placement of the catheter with the introducer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/516,249, filed Oct. 16, 2014, now U.S. Pat. No. 10,143,413, issuedDec. 4, 2018, entitled “CATHETER INSERTION DEVICE WITH BLOOD ANALYZER”,which claims priority from U.S. Provisional Patent Application No.62/011,741, filed Jun. 13, 2014, entitled “CATHETER INSERTION DEVICEWITH BLOOD ANALYZER”, the disclosures of which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present device relates to catheter insertion devices and bloodtesting equipment. More particularly, the disclosed device, and methodrelates to a catheter assembly adapted for engagement with a needlewhich includes a visually discernable signaling component configured tovisually change appearance upon communication thereto of blood having adetermined level of substance therein. The visual change provides theuser an alert to blood levels of certain components during the provisionof emergency services which may be of immediate concern, such as bloodsugar levels or alcohol levels.

BACKGROUND OF THE INVENTION

Intravenous catheters for the infusion of fluids into the peripheralveins of a patient are one of the most common devices employed inhospitals and especially by Emergency Service Technicians responding toa scene where the patient requires emergency medical care. In providingmedical services to a patient, emergency healthcare providers frequentlyare required to insert a catheter into the patient on arrival or beforetransport. Hospital medical personnel have the same requirements intending to a patient.

The insertion of a catheter allows the medical provider to providemedications, fluids, blood, and blood plasma directly into thecirculatory system of the patient. In the case of emergency responders,the insertion of a catheter also provides line access for subsequenthospital personnel, to allow for immediate care upon arrival at ahospital.

During insertion of a catheter into a patient's blood vessel, a catheterinsertion device or introducer, is engaged with a catheter assembly. Theintroducer having a hollow needle, is inserted to puncture the intendedblood vessel of the patient. As a signal to the medical provider thatthe needle successfully communicated into the blood vessel, bloodtravels through the length of the hollow needle and exits into avisually discernable flash chamber, in a surge commonly called aflashback.

The typically transparent flashback chamber of an introducer therebyserves as a visual indication of successful entry into the blood vessel.Concurrently, the flash communication of blood into the chamber alertsthe medical provider that further insertion of the needle of theintroducer, may cause the needle to pierce the blood vessel's opposingwall. Flash chambers in catheter introducers used to insert catheterassemblies are sized such that they fill with blood within a very shorttime period to allow the medical provider to verify the needle hasreached its mark.

Catheters may be produced in two general forms, though-the-needlecatheters, in which a catheter is threaded through the needle cannula ofthe introducer and into the vein of a patient, and over-the-needlecatheter assemblies, in which the needle of the introducer and coaxialouter catheter, are inserted into the vein or artery concurrently,whereafter the needle is withdrawn through the catheter uponverification of blood communicated to the flash chamber of properpositioning.

In typical catheter insertion assemblies, for use by emergencypersonnel, the user removes and disposes the contaminated needle andintroducer after a proper catheter assembly positioning.

Alternatively, a tab on the needle guard is employed to allow the userto simultaneously thread the catheter tube into the blood vessel andretract the needle of the introducer from the catheter tube. The needleguard then slides and locks into place to protect the user and othersfrom the contamination.

Emergency responders, on arrival to an incident, conventionally checkseveral vital signs before and during transport to a hospital. The sameoccurs in a hospital emergency room when a patient arrives who has notbeen transported by an ambulance.

During this process the emergency provider begins to diagnose or treatthe patient for perceived medical problems to save vital time for theemergency room doctors and increase the chances of survival duringtravel from the emergency site to a hospital.

A particular concern arises when the emergency personnel have to dealwith an unconscious patient or one who cannot communicate. Withunconscious patient or patients, who may not be breathing or have othersubstantial risks of death, the emergency personnel treating the nonresponsive patient are unable to ask the patient about their backgroundor injury of possible causes of their health emergency. In the heat ofthe moment, while treating an unresponsive patient, and attempting toascertain why the patient is non-responsive, frequently overlooked isthe issue of blood sugar levels which might have caused the patient tobecome unresponsive. Such frequently occurs in diabetic patients. Thesame problem can occur with unconscious patients who have ingested drugsor may be having an allergic reaction.

With patients suffering from blood sugar issues, the diagnosis of low orhigh blood sugar levels in the blood, or with patients where otherchemical substance levels in the blood which might cause the patient tobe unconscious or unresponsive, such are not always discovered at thisearliest stage of treatment when such information could significantlychange the course of treatment, and the patient's outcome.

This can occur due to the emergency situation to which the medicalprovider arrives upon, or in an emergency room when the surroundings arehectic, and where the health care provider is concerned withascertaining if the patient is breathing, and concurrently trying toplace a line into a vein of the patient to provide fluids and/ormedication.

This current inability for a quick diagnosis can often further injurethe patient when, for example, hyperglycemia or hypoglycemia in adiabetic patient can easily be mistaken as alcohol intoxication orstroke. The patient may be transported without ascertaining or treatingthe cause of the emergency. Thus, valuable time is lost in treating theactual problem if the reason for a patient's non-responsive state is notascertained quickly.

As such, there is an unmet need for an intravascular catheter insertiondevice and method, which concurrent with the positioning of a catheter,provides a means for visually alerting the medical provider, todiscerned causes of non-responsive patients which can be achieved fromblood analysis. Such a device should be employable concurrent with theinsertion of a catheter assembly in the patient, with no extra effort bythe user, and concurrently provide the visually discernable alert shouldblood from the patient have levels of substances past a threshold. Sucha device and method should allow a health care provider to quickly andeasily view test results, for a range of blood-discoverable disorders,immediately subsequent to the communication of blood from a patient, tothe flash chamber of the introducer or angio catheter hub, during thecatheter insertion process.

The forgoing examples of related art and limitation related therewithare intended to be illustrative and not exclusive, and they do not implyany limitations on the invention described and claimed herein. Variouslimitations of the related art will become apparent to those skilled inthe art upon a reading and understanding of the specification below andthe accompanying drawings.

OBJECTS OF THE INVENTION

It is an object of the present invention to provide a device adapted foruse with an intravenous catheter insertion component, which duringnormal employment thereof is used to place a venous line, and whichprovides visually discernable feedback to the user, of a concurrentblood analysis.

It is an additional object of this invention for such a visual alert toa patient health problem, such as a colorimetric reagent, to beactivated by communication with blood plasma from blood reaching theflash chamber during a catheter insertion, for easy viewing and quickanalysis.

It is yet an additional object of this invention to provide and visuallydiscernable blood content analysis device and method which when placedin communication with blood or plasma concurrent with the insertion of aline or catheter, will provide the user with a visually discernableresult to the presence of a substance or threshold amount thereof in theblood of the patient being given the line.

These and other objects, features, and advantages of the presentinvention, as well as the advantages thereof over existing prior art,which will become apparent from the description to follow, areaccomplished by the improvements described in this specification andhereinafter described in the following detailed description which fullydiscloses the invention, but should not be considered as placinglimitations thereon.

SUMMARY OF THE INVENTION

In accordance with the purposes of the present invention, as embodiedand broadly described herein, the present invention provides a visuallydiscernable warning or result in a component adapted for operative fluidcommunication with the flash chamber of an introducer for an intravenouscatheter into a blood vessel of a patient. The device and methodprovides a visually discernable alert when blood from the flash chamberof a catheter introducer, or in some modes, a sealed luer lock,communicates with a test component reactive to communicated bloodplasma, to visually change. The reaction with the blood or the plasmaoccurs depending on one or a plurality of reagents positioned thereinconfigured to test for blood contents, substances or threshold high orlow levels thereof, to visually change in appearance upon a result.

The device and method may be employed by engaging the reagent testingcomponent to existing introducers in an operative manner, or, it may bepracticed through the provision of an introducer having the testingcomponent formed integral or engagable therewith in production as acombination introducer and testing component. This may be with anengageable testing component or employing a testing component as part ofthe flash chamber components.

The overall object of the device and method herein is the provision ofan introducer for a catheter which will employ the blood communicated tothe flash chamber, to test for substances carried in, or lacking, orbelow or above a threshold level, in the blood communicated thereto.Such will occur concurrently with the positioning of the catheter andprovide a visually discerned alarm or alert to the user if a testedsubstance is present, lacking, or present above or below a thresholdlevel for which the blood is concurrently tested during catheterinsertion. In another mode, the same testing component can be configuredto be engageable with the introducer, or can also be engaged with andemployed to receive communicated blood from a sealed leur lock.

The test component, so positioned in operative engagement with anintroducer, during use thereof, will provide an immediate visuallydiscernable alert to the user, of a particular patient condition whichis discernable using blood or blood plasma and a reactive reagent. Thereagent or reagents operatively positioned on the test component can beconfigured to react and produce a visually discernable alert to the userof conditions of the patient. This can include low or high blood sugaror excessive alcohol levels, opiate levels, or the presence of otherchemicals and substances which are discernable using blood plasmacommunicated to an introducer which has a communicating test component.This is especially helpful to emergency personnel who are confrontedwith an unconscious or non-responsive patient because a number of causeswhich may be discerned with a blood analysis, can be confirmed oreliminated concurrent with the insertion of a venous catheter.

During insertion of a catheter with an insertion set, the needle of theintroducer in conventional sets, has a distal end which communicateswith the flash chamber which extends through the needle hub, and acoaxial catheter. A small point of the introducer needle extendscoaxially through the insertable catheter and has a point which extendsfrom the distal end of the catheter.

The testing component if positioned in or in communication with theflash chamber can contain one or more one-way air valves or membranes toallow air to escape as blood enters the flash chamber. The bloodcommunicated to the flash chamber conventionally provides visualconfirmation of placement of the needle point and distal end of thecatheter into a vein or artery. This signals the user the line isproperly placed.

In one mode of the device and method, the rear of a conventional flashchamber, which is conventionally plugged by a microporous plug, caninclude a visually discernable means of alerting the user to a healthcondition, such as a colorimetric sheet or layer having a reagentthereon which is reactive to blood or blood plasma contents. Such testsheets are well known in the art and can be employed to test for thepresence of a substance or marker therefor or differing levels thereofin the communicated plasma or blood. Such microporous plugs areconventionally positioned in most introducer flash chambers and thus inone mode, employable for the device and method herein, can be adaptedusing the mode of the device and method herein to include one or aplurality of reagent layers in fluid communication with the flashchamber or the microporous plug, which are visually discernable throughthe sidewall of the introducer.

In another preferred mode of the component herein, a reactant to bloodcontent levels for certain chemicals and contents is placed in a fluidcommunication with the flash chamber, using a housing and testingcomponent which may be placed inside, or outside the flash chamber. Apathway for blood flow to the housing is provided axially or through asidewall of the introducer.

The housing of the engaged or engageable test component, will housematerial which includes one or a plurality of reagents operativelypositioned on sheets or membranes, which are visually reactive tocertain blood conditions such as blood sugar levels, alcohol levels,opiate presence or levels, or individual drugs or other substances beingpresent in the patient's blood. Such may be a paper or plastic materialwith a reactive agent therein which produces a visually discernablechange such as a color change upon communication with blood or bloodplasma. The paper or plastic material hosting the reagent, as noted, maybe placed within the flash chamber, or against a sidewall thereof whereit is viewable, or within a sub chamber, or engageable testingcomponent, so long as the reagent contained in the housing, is engagedto achieve a fluid communication with the blood communicated into flashchamber during a catheter insertion.

The testing component as noted may be formed to be removably engageablewith the introducer housing to fluidly communicate with the flashchamber to allow the user to engage a testing component having a reagentor reagents operatively positioned therein and adapted to test for oneor a plurality of suspected substance levels. Alternatively, it can beengaged at manufacture either axially, or on a sidewall of the housingof the introducer such that it is in a fluid communication with theflash chamber.

In one mode, the visually discernable result or alert can include acolorimetric sheet composed of two layers. A first or outer layermembrane is exposed to blood first and acts as a filter to filter outthe red blood cells and pass plasma. A second or inner layer is incommunication with the passed plasma and contains one or more reagentswhich will visually change to a certain color or colors in the presenceof an analyte being tested, and can thereby show the presence of asubstance or a presence below or above a threshold level.

Small sheets or other types of reagent material may be placed on oragainst the sidewall of the flash chamber, or within communicating subchambers of a testing housing engaged or engageable to a fluidcommunication point with the flash chamber of the introducer. Thereagent strips or layer may also be placed in another viewable positionso long as the reactive layer is placed in a communication with thefluid within the flash chamber, and provides a result that is visuallydiscernable when viewed by the user.

As blood that enters the flash chamber it concurrently contacts andpasses through the filter layer and communicates plasma to contact thecolorimetric sheet. Thereafter the reagents within the sheet, willchange to a certain color, or sequence of colors, to alert the medicalpractitioner as to the presence or absence of certain chemicals ormaterials or substances in the blood, or one or a plurality of thresholdlevels of such substances within the blood communicated to the flashchamber.

As such, a colorimetric sheet may be placed on a viewable sidewall ofthe microporous plug per one preferred mode, or in a housing within, orexterior to the flash chamber, or affixed to a wall surface of the flashchamber, or in engaged or engageable component housings or chambers, sothat the user can view a visually discernable result such as a colorchange reaction through the transparent sidewall of the introducer orflash chamber.

The colorimetric sheet should be sufficiently sized and contain thenecessary amounts or number of reagents so that a user could discerncolor changes from chemical reactions with the volume of blood housedcommunicated from the flash chamber. Additionally, in any of the modesof the device and method herein, the material hosting the reagent, caninclude a plurality thereof which can be combined to perform severaltests at once, and provide multiple viewable results to the user.Further, the colorimetric sheet can be composed of any currentlyemployed substrate material and one or a combination of colorimetricreagents adapted to provide a visual change in appearance upon reactingwith one or more elements contained in the blood or plasma.

Additionally, any color reactive material or chemical which will changecolor or colors in a visually discernable alert to the user, when placedin operative communication with blood or plasma from the flash chambermay be employed if it will react at some threshold level to alert theuser visually. Such may be any dry chemicals or gelled chemical orliquid chemical or material which is placed in sub chambers incommunication with the flash chamber which will visually react and alertthe user.

With respect to the above description, before explaining at least onepreferred embodiment of the herein disclosed blood testing invention indetail, it is to be understood that the invention is not limited in itsapplication to the details of construction and to the arrangement of thecomponents in the following description or illustrated in the drawings.The visual alert device adapted for use concurrently with an introducerherein described and disclosed in the various modes and combinations isalso capable of other embodiments and of being practiced and carried outin various ways which will be obvious to those skilled in the art. Anysuch alternative configuration as would occur to those skilled in theart is considered within the scope of this patent. Also, it is to beunderstood that the phraseology and terminology employed herein are forthe purpose of description and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be utilized as a basisfor designing of other catheter insertion devices and blood testingequipment for carrying out the several purposes of the present discloseddevice. It is important, therefore, that the claims be regarded asincluding such equivalent construction and methodology insofar as theydo not depart from the spirit and scope of the present invention.

BRIEF DESCRIPTION OF DRAWING FIGURES

The accompanying drawings, which are incorporated herein and form a partof the specification, illustrate some, but not the only nor exclusiveexamples of embodiments and/or features of the disclosed device. It isintended that the embodiments and figures disclosed herein are to beconsidered illustrative of the invention herein, rather than limiting inany fashion.

In the drawings:

FIG. 1 depicts an isometric view of one mode of the device and methodhaving a microporous plug testing and alert adapted for employment withan introducer during placement of a venous catheter.

FIG. 2 shows a side view of the device and method herein wherein a testcomponent is adapted for sealed engagement with a proximal end of anintroducer in operative fluid communication with the flash chamberthereof.

FIG. 3 depicts a sectional view of the device of FIG. 2.

FIG. 4 shows a mode of the device and method herein wherein the deviceis configured as a removably engageable test component adapted foroperative engagement with the introducer and flash chamber of anintroducer.

FIG. 4a shows the device of FIG. 4 also having a slot adapted forengagement with an electronic blood testing component.

FIG. 5 depicts another mode of the device herein showing an internal orintegral construction reagent housing which yields the visual report oralarm on communication with blood or plasma.

FIG. 6 depicts a mode of the device positioned in a housing in operativeengagement on the exterior of an introducer and in operativecommunication with the flash chamber.

FIG. 7 shows an exploded view of the introducer-engaged housing for thereagent layer or layers.

FIG. 8 shows a mode of the device having a circular configuration suchas would be employed as the microporous plug in the depiction of FIG. 1.

FIG. 9 depicts the device of FIG. 8 in an exploded view.

DETAILED DESCRIPTION OF THE INVENTION

Now referring to drawings in FIGS. 1-9, wherein similar components areidentified by like reference numerals, there is seen in FIG. 1, thedevice 10 positioned with the means for substance testing of blood orplasma such as a testing component 12, positioned in direct fluidcommunication with the flash chamber 14 of a conventional introducer 16.The introducer 16 as conventionally employed, has a needle 18 whichextends within the axial passage of a catheter 20 in sealed engagementwith a luer lock 22 component. The device 10 and method herein, in allmodes includes a testing component 12 having substrate such as a pad ormembrane or sheet of material with a reagent or other substance thereonwhich reacts with substances in the blood in a manner to provide avisually discernable means for alerting the user. Such when viewed bythe user will alert them to the presence, non-presence or a thresholdlow or high level, of that particular substance, chemical, or contentsof the blood or blood plasma, which is communicated thereto, and whichreacts to such a fluid communication with blood or plasma, such andchanges appearance, such as color.

The various modes of the testing component 12 primarily depict asubstrate of planar material adapted to the task. However, the substrateis capable of numerous other modes, and any testing component 12 orother component which may be placed in operative fluid communicationwith a flash chamber 14 of an introducer 16, and which will react in avisually discernable manner to a communication of blood or plasmathereto when a particular substance, chemical, or other element carriedin the blood, is considered within the scope of this application.

A colorimetric reagent pad 32 is preferable to determine theconcentration of glucose in blood plasma and provide a visuallydiscernable means for the user to view results or an alert. A thresholdindication system may be used such that when the concentration is belowa predetermined level, the reagent pad 32 remains colorless, and whenthe concentration goes above that point, a colored dye is activated inthe reagent pad 32, and can be detected easily by the human eye.

In a preferred variation, a dual threshold indication system is usedsuch that the reagent pad 32 remains colorless below a predeterminedlevel, changes one color when above the first threshold, and turns asecond color when above the second threshold. An example of the dualindication system would be such that the reagent pad 32 is colorlessbelow a glucose concentration of 80 mg/dl indicating low blood sugar,green when between 80 mg/dl and 300 mg/dl indicating normal blood sugar,and dark blue when above 300 mg/dl indicating high blood sugar.

The threshold indication system is accomplished through precise controlof the volume of plasma that is able to contact and react on thesubstrate such as the reagent pad 32, and using precise amounts ofscavenger molecules that are consumed before the reaction with the dyeis visible. This can either be accomplished by consuming an intermediatereactive species or quickly reacting to turn the dye back to a colorlessstate once it has reacted with the intermediate reactive species. Onceall the scavenger molecules have reacted, reactions can proceed with thedye or the dye is no longer reversed to a colorless state.

In the dual threshold variation, reaction speeds are controlled throughenzyme concentrations and the concentration of other reactive speciessuch that the scavenger molecules are reacted before the other two dyesare able to react at an eye-detectable level. The first dye, which isalso present in a precisely controlled amount like the scavengermolecules, then reacts before the second dye is able to react at aneye-detectable level. But once all the first dye has reacted, thereaction proceeds onto the second dye.

The reagent pad 32 form of the test substrate, may be created byconventional means in the art such as by dipping a hydrophilic membranesuch as filter paper into a solution containing all the startingchemicals and enzymes. Through control of the concentration of chemicalsin this solution, and conventional knowledge about how much solution isadsorbed onto the reagent pad 32 during dipping, the amount of startingchemicals can be controlled.

For example, and in no way limiting as to the substance which can bevisually discerned using the device 10 and method herein, glucose isfirst reacted with an enzyme to give rise to a more reactive speciesthat is able to react appropriately with either the scavenger moleculesor dyes. In one embodiment, glucose reacts with the enzyme glucoseoxidase and oxygen to create gluconic acid and hydrogen peroxide.

Hydrogen peroxide then proceeds to react with a colorless phenolic inthe presence of 4-aminoanipyrene (AAP) and the enzyme horseradishperoxidase to create a colored dye and water. This is explained furtherin U.S. Pat. No. 6,599,474 B2.

There is a wide range of phenolic compounds that can be used, and onethat gives a light green color when reacted with AAP is3-hydroxyquinaldine [2].

To create a threshold visually discernable indication, a reducing agentcan be used to convert the colored dye back into a colorless form asshown in reaction. Some possible reducing agents that could participatein reaction include ferrous sulphate and magnesium chloride.

A scavenger compound can also be used to create a threshold indicationby consuming the majority of the hydrogen peroxide before it canparticipate in reaction (2) and indicate the dye. One such compound,1-cysteine can react directly with hydrogen peroxide.

If may be desirable to control the reaction enzymatically, and ascorbatecan be used in conjunction with glutathione to do so for example. Anadvantage to using enzymatically controlled reactions is that enzymeconcentrations can be used to obtain better control over reaction rates.

Note, that because ascorbate is regenerated in such a reaction, thestoichiometrically controlled species for creating a thresholdindication is glutathione.

For the secondary threshold indication, hydrogen peroxide reacts withiodine ions and hydrogen ions to create triiodide and water. Thetriiodide can then form a deep blue complex with starch. Some controlover the reaction rate can be achieved by controlling the pH andconcentration of iodine ions.

An alternate to using hydrogen peroxide as the reactive species is NADH.This is described in U.S. Pat. No. 5,200,325. Glucose reacts with NAD+and the enzyme glucose dehydrogenase to create NADH and gluconolactone.The NADH is the reactive species that continues on to the nextreactions.

Pyruvate can be used as a scavenger to stop any activation of a dyebelow a specified threshold of glucose. The conversion of the lactateinto acetate ensures that the lactate does not undergo a reversereaction or involve itself in any side reactions.

Once all the pyruvate is consumed, the NADH can proceed to react with anindicator in the pad. In the presence of lipoamide dehydrogenase, NADHcan react with lipoamide (LA) to create a reduced form of lipoamide.

The reduced form of lipoamide can react with various disulfideindicators to create color. For example,2,2′-dithio-bis(pyridine-N-oxide) (DTPO) may be employed. The reducedform of the disulfide indicator produces color. The amount of LA andDTPO can be precisely controlled along with the amount of lipoamidedehydrogenase enzyme to have all the DTPO and LA be in a reduced stateat a desired threshold concentration of glucose. Once all the DTPO andLA are in a reduced state, a second threshold reaction can become theprimary indication. In this case the NADH can proceed to react with2-(p-iodophenyDJ-(p-nitrophenyl)-5-phenyltetrazolium chloride (INT) inthe presence of the enzyme diaphorase to create NAD+ and formazan, thecolored indicator and reduced form of INT.

This is an example of a dual threshold color indication using NADH asthe reactive species. The colors of the specific indicators used in thisexample may not be optimized for this application, but it is expectedthat there are multiple colors that can be produced with similarmolecules to the ones used. The reagent pad 32 or testing substrate, canbe formed to be ethanol sensitive by changing glucose oxidase to alcoholoxidase in the first reaction noted above which generates hydrogenperoxide. Similarly, glucose dehydrogenase can be replaced with alcoholdehydrogenase which generates NADH in reaction. The rest of thechemistry should proceed similar to above.

The aforementioned are simply examples of modes of enabling the device10 with a reagent pad 32 which after a duration of time of exposure tocommunicated blood plasma, will visually react to the presence of asubstance or analytes thereof in the blood plasma, or to analytes of asubstance or the substance itself above a threshold level. The employedtesting substrate such as depicted reagent pad 32 can be segmented tomultiple zones to include multiple reactions to the communicated plasma,to provide multiple individual visually discernable alerts forrespective multiple individual substances present, and/or above or belowthreshold levels by volume.

As depicted in FIG. 1, a conventional catheter 20 insertion device suchas an introducer 16 is equipped with some form of colorimetric-enabledtesting component 12 having a substrate such as the shown reagent pad 32which will visually change in appearance if a substance such aschemical, drug, or other element or substance in the blood communicatedto it, is present, or present at above or below a threshold level. Shownin the modes of FIGS. 1-9, a conventional introducer 16 includes atubular housing 17 defining a body and reservoir for the flash chamberwhich has a hollow needle 18 extending therefrom though the axialpassage in the catheter 20. An axial conduit communicating through theneedle at both ends, is in an operative sealed communication with theformed flash chamber 14 in the housing 17, which is formed ofsubstantially transparent material such that the interior of the flashchamber 14 is viewable through the sidewall surrounding it.

In all modes of the device 10 where the needle 18 is coaxial to thecatheter 20, the point of the needle 18 is seen to extend from thedistal tip of the catheter 20, which is mounted on the luer lock 22component. This allows the needle 18 to be inserted through the flesh ofthe patient and be positioned within the desired vein or artery.

Upon a proper communication of the distal end of the needle 18 with theinterior of a vein or artery, blood immediately flows through the axialconduit of the needle 18 and into the flash chamber 14 therebysignifying proper positioning. The flash chamber 26 on conventionalintroducers 16 can contain one or more one-way air valves, or membranes,to vent or allow air to escape as blood enters. Conventionally one suchair passage is provided by a flash plug 26.

As shown in FIG. 1, at the rear of many conventional flash chambers 14in conventional introducers 16, is located a microporous plug 26. In onepreferred mode of the device 10 herein, as for instance in FIGS. 1 and8-9, the testing component 12 or another means for producing a visuallydiscernable alert, upon communication with blood or plasma in the flashchamber 14 which has a particular content or threshold level of aparticular analyte for a substance or the substance itself, may bebarrel-shaped or the testing substrate may be positioned on, or formedas part of, the flash plug 26 in a position where it is viewable througha wall of the introducer body.

In another preferred mode of the device 10 per FIGS. 2-4 the means forproducing a visually discernable alert or test result for the user, to ablood content of a particular substance analyte, marker, or thesubstance itself, over or under a threshold level, shown as a testingcomponent 12, using an appropriate substrate material which is formed inan engaged or engageable barrel or circular shape for example as shownin FIGS. 4 and 4 a.

In operation herein, in all modes where a testing component 12 isemployed, blood from the flash chamber 14 is communicated to the testingcomponent 12. During such communication to the testing substrate, plasmais separated from the whole blood using a plasma separation membrane 30(FIGS. 4-4 a and 8-9 for example) such as that available from PallCorporation for example. The plasma separation membrane 30 prevents redblood cells from coming in contact with the reagent pad 32 anddistorting the color. The plasma will be able to wick through the plasmaseparation membrane 30 (PSM) while the red blood cells are left behind.A similar membrane 30 is described in U.S. Pat. No. 5,972,294, and anexample currently available for sale is VIVID Plasma Separation Membraneby Pall Corporation.

Red blood cells have an approximate diameter of 6.2-8.2 μm and by usingan asymmetric membrane 30 where the pore size varies in a gradientstarting on the receiving side from values such as 50 μm to 0.1 μm, redblood cells will be trapped in the receiving side of membrane. Themembrane itself is made of a hydrophilic material that will readily soakup and wick plasma, so the red blood cells are trapped on the receivingside of the membrane while the plasma is wicked to the opposite end.This ensures that only plasma will soak into the reagent pad.

In one preferred mode of the device 10, it is desired to induce a bloodclot between the blood in the flash chamber 14 and that which iscommunicated through the plasma separation membrane 30 to the testsubstrate as a means for limiting the volume of fluid communicatedthrough the membrane 30, and then to the reagent pad 32, to stop anexcess communication and a continuous diffusion of glucose for examplewhich can cause a testing error.

Means to induce clotting on or in the membrane 30 such as by causingblood clots, may be induced by several different compounds. Potassiumferrate is one used in U.S. Pat. No. 6,187,347 B1, and kaolin andzeolite are used in US patent application US20090299253 A1. Blood has anatural clotting cascade to seal up wounds to the body, and it may bedesired to induce and accelerate clotting to seal up the plasmaseparation membrane 30 in instances where the testing being donerequires a certain volume of fluid communicated to the substrate havingthe visually discernable test results thereon to be accurate.

The clotting speed, and therefor the volume of plasma or fluid passedthrough the membrane 30, may be tightly controlled by varying the amountof the clotting agent on, adjacent to, or within the separation membrane30, to allow plasma flow before clotting only for a sufficient time fora determined volume of blood plasma to communicate through the plasmaseparation membrane 30, and thereby stop glucose diffusion in thetesting component, beyond that point in time where the volume of plasmapasses through.

An alternative, described in patent application WO2010062734 is usingchitosan, which does not induce the full clotting cascade, but onlyforms a localized clot. It may be desirable to pattern the chitosan insuch a way on the plasma separation membrane 30, such that there is not100% coverage initially, but after contact with the blood and subsequentwicking through the plasma separation membrane, all contact of blood tothe plasma separation membrane 30 has ceased after the desired amounthas been absorbed. In a preferred embodiment, a chitosan gel or solutionis cast or sprayed directly on the plasma separation membrane and dried,forming a layer. The chitosan matrix molecular weight and thickness istightly controlled to allow a precise amount of plasma through theplasma separation membrane before being sealed.

Thereafter, the plasma wicks from the plasma separation membrane 30 andfluidly communicates with the substrate providing the visuallydiscernable outcome to the test component 12 such as the reagent pad 32.The reagent pad 32 may be configured in any manner of conventional waysto produce a visually discernable alert, such as a color or colorchange, when a threshold level of a substance analyte or the substanceitself being tested-for, is discerned. The reagent pad 32 may remain theoriginal color if the agent or material being tested for is not presentin the plasma, or if it is present below a specified concentration. Ifthe concentration is above the specified level, the reagent pad 32 willhave a colored change indication detectable by the human eye.

Shown in FIGS. 2 and 3, the testing component 12 is positioned to be ina fluid communication with blood communicated thereto, at the rear ofthe flash chamber 14, in place of the plug of FIG. 1. As depicted, thesubstrate employed as the testing component 12 is positioned within asubstrate housing of a tubular or barrel shape and has a bloodcommunication and testing system within such as those of FIGS. 4-4 a.Also, in this mode, the testing component 12, might be one of aplurality of substrates which are positioned in differing engageabletesting components 12 available for such testing, and engaged with areagent housing 36 which is configured for a sealed engagement with thehousing 17 of the introducer 16. This engagement is by cooperativefasteners formed or positioned on each, and may be a threaded engagement37, which places the testing component 12 such that the substrate orsubstrates providing the visually discernable result to fluidcommunication with the flash chamber 14, or may be a frictionalengagement achieved when a tapered first end is engaged in an apertureat the rear of the housing 17 of the introducer 16.

This engageable configuration would allow the employment of a kit oftesting components 12 such as in FIGS. 2-4 a, with each configured withone or more substrates within a substrate housing, with proper chemicalreagents imparted or positioned thereon, to produce a visuallydiscernable alert, to the presence of a different particular chemical,component, or substance in the blood. Thus the user could pick oneengageable testing component 12 from the plurality in the kit thereof,and employ it during an introduction of a catheter on a patient, to testfor a particular substance during insertion. It should be noted that thetapered first end shown for the testing component 12 of FIGS. 2-4 a, mayalso be employed to engage with a sealed leur lock of a catheter alreadyplaced in a patient, to perform a quick test for blood levels ofparticular substances to which the testing component 12 is configured toreact. The tapered portion will engage in the aperture of the luer lockand open it temporarily for fluid communication to the substrate withinthe substrate housing of the test component 12.

In FIGS. 4 and 4 a, can be seen sectional views of the axial-engageablemode of the testing component 12. While shown in a frictional engagementof the tapered first end of the housing wall 37, which is adapted toengage an aperture 39 through the housing 17 of the introducer 16, athreaded twisting engagement through the aperture 39 (not shown but wellknown) could also be employed, or mating cooperative fasteners on boththe housing of the introducer 16 and the testing component 12 beingattached.

As shown in FIGS. 4-4 a, a wall 37 forms the exterior of the substrateor reagent housing 36 and is tapered at a first end which has anaperture 47 providing fluid communication to the substrate positionedwithin the interior of the substrate or reagent housing 36. A wickingmaterial 51 or plasma separation membrane 30, depending on construction,receives blood in the fluid communication from the flash chamber whenoperatively engaged such as in FIG. 3.

Blood is communicated to the blood to a plasma separation membrane 30which filters the red cells and passes blood plasma to the testsubstrate shown in this mode as reagent pad 32. Also shown in FIG. 4a ,is a recess 49 formed into the wall 37 of the housing 36 on both sidesextending from the edge of the aperture 47. This recess 49 extendstraverse to the center axis of the housing 36 such that an elongatedconventional blood test strip (not shown) used to test blood forsubstances, can be engaged within the recess 49 and drops of bloodabsorbed by the wicking material 51 can be communicated to the teststrip, to test for a blood born substance if such is not being testedfor by the device 10. Currently, users of introducers use blood whichdrips from the sharp needle, at great risk to a puncture wound tothemselves, to accomplish the transfer of patient blood to a test strip.

Plasma communicating to and through the reagent pad 32 will communicatethrough a moisture indicator layer 33 and thereafter cease furthercommunication rearward once it encounters the backing layer 35 which isconfigured to pass air from the flash chamber 14 to the atmosphere butblock the larger fluid molecules from exit. The backing layer 35 thusprovides means for venting air from the flash chamber 14 to allow bloodand plasma to fill it.

The reagent pad 32 or substrate, as noted herein, in all modes of thedevice 10 such as of FIG. 1, 2-4 a, or 5-7, will be imparted withappropriate reactive substances to visually react to a determinedsubstance in the blood plasma, and change in appearance and provide avisual alert to the user, of the presence or lack of presence of asubstance in the blood of the patient. This can be seen through thesidewall of the introducer housing 17, or the housing of the engaged orengageable testing component 12, no matter the location or means ofengagement with the introducer 16.

As shown in FIGS. 5-7 the testing component 12 can be elongated orplanar in configuration, and be engaged to the interior of the flashchamber as in FIG. 14, or the exterior of the flash chamber 14 as inFIG. 5 or be formed integral with the walls defining the introducer 16or flash chamber 14. In either mode, a passage 41 will be operatively bepositioned to communicate blood from the flash chamber 14, to the one ora plurality of substrates such as reagent pads 32 shown for instance inFIG. 7 in the exploded view of this mode of the device 10.

A transparent wall or cover 43 is placed in sealed engagement with abase 45, (which may be the wall forming the flash chamber 14) and one ora plurality of apertures 47 will communicate with passages 41 providingfluid communication with the flash chamber 14. This mode can be formedintegral to the housing 17, or engaged on the exterior thereto usingadhesive or other means to engage the base 45 or the cover 43 to a wallof the housing 17. Or, as noted, if manufactured, it may be formedintegral to the wall defining the flash chamber 14 or introducer 16.

In all modes of the device 10 the testing component 12 can includesubstrate adapted with appropriate test material to produce a thresholdvisually discernable alert, which may have one, or a plurality ofconcurrent different visually discernable results possible. As shown inFIG. 7, the testing component 12 includes the separation membrane 30which communicates the plasma to the exterior which has a plurality ofsections formed thereon, with each section providing a differingvisually discernable alert, such as colors, to the user showing thepresence in the blood tested of the particular component, chemical, orsubstance in the blood at a particular level. For example the reagentpad 32 of one section, can remain colorless below a specifiedconcentration, and in a second section as shown, there may be an alertfor another tested substance being present in the blood or a differentlevel of the first component tested.

As shown in FIGS. 8-9 the testing component 12 providing the visuallydiscernable alert or alerts, may be cylindrical such as when employed asthe flash plug 26 in a conventional introducer 16. In this mode, theseparation membrane 30 communicates plasma therethrough to the reagentpad 32 or pads, which will then visually provide a result or alertconcerning the level or presence of a substance in the sampled blood.Plasma will also communicate through a moisture indicator layer 33 whichin all modes changes appearance to signify moisture communicationthereto, and thereafter cease further communication rearward once itencounters the backing layer 35 which is configured to pass air from theflash chamber 14.

Particularly preferred in any mode of the device 10 when used in anoperative engagement with an introducer 16 would be a colorimetric bloodglucose or ethanol test, using a substrate such as the reagent pad 32configured to provide a visually discernable alert, when blood glucoseor ethanol concentration is beyond a predetermined point whereby thereagent pad 32 reacts in a manner to provide a visually discernablealert or result.

However, any substance or level thereof in the blood may be tested and avisually discernable alert produced using the appropriate reagents whichreact to the presence of a substance or marker for such in the blood.This provides the medical provider with valuable information concurrentwith the introduction of the catheter to the patient with no extraeffort or time.

Any of the catheter components as described above can be produced fromany of the standard disposable and non-toxic plastics or metals usedwith other intravenous catheters. The color indicator providing avisually discernable alert to the user for the substance or level ofsubstance in the blood communicated to a flash chamber 14 may be anymaterial which will react to such substances in the blood and providethe visual alert which as known to those skilled in the art may be anyof thousands of potential tests and resulting visually discernablereactions.

In a method of use of the device 10 herein, a user will employ anintroducer 16 to place a catheter in the vein of a patient. In a firststep, if the introducer 16 is pre-configured with a testing component 12in communication with the flash chamber 14 of the introducer 16, theuser will pierce the vein of the patient and discern if blood iscommunicated to the flash chamber 14. Subsequent to such communicationto the chamber 14, the user will view the reagent pad 32 within thetesting component 12 to ascertain if a visually discernable alarm orresult has been found.

If employing an introducer 16 without a pre-mounted testing component12, the user will choose a testing component 12 from a group which willprovide a desired visual alarm to the presence of a substance or levelthereof once blood from the flash chamber 14 reaches it. The user willengage the testing component 12 into an aperture of the introducer 16which is configured to communicate plasma to the testing component 12.Thereafter the user will engage the needle of the introducer 16 with thevein of a patient, whereby blood will communicate to the flash chamber14, and cause the substrate or reagent pad 32 of the chosen testingcomponent 12 engaged, to react and either provide a visually discernablealarm or result to the user if the substance being tested for is presentor is present at a level above a threshold.

As noted, any of the different configurations and components can beemployed with any other configuration or component shown and describedherein. Additionally, while the present invention has been describedherein with reference to particular embodiments thereof and steps in themethod of production, a latitude of modifications, various changes andsubstitutions are intended in the foregoing disclosures, it will beappreciated that in some instance some features, or configurations, orsteps in formation of the invention could be employed without acorresponding use of other features without departing from the scope ofthe invention as set forth in the following claims. All such changes,alternations and modifications as would occur to those skilled in theart are considered to be within the scope of this invention as broadlydefined in the appended claims.

Further, the purpose of any abstract of this specification is to enablethe U.S. Patent and Trademark Office, the public generally, andespecially the scientists, engineers, and practitioners in the art whoare not familiar with patent or legal terms or phraseology, to determinequickly from a cursory inspection the nature and essence of thetechnical disclosure of the application. Any such abstract is neitherintended to define the invention of the application, which is measuredby the claims, nor is it intended to be limiting, as to the scope of theinvention in any way.

What is claimed is:
 1. A blood testing apparatus adapted for fluidcommunication with a catheter or needle that is inserted into a vein orartery of a patient to convey blood from the patient, the apparatuscomprising: a housing that defines a flash chamber, the flash chamberbeing adapted for fluid communication with the catheter or needle; asubstrate configured to generate, upon contact with a portion of theblood in the flash chamber from the catheter or needle, a visuallydiscernable reaction to a presence or a threshold level of a substancein the blood, the visually discernable reaction being viewable throughthe housing; and a fluid communication pathway between the substrate andthe flash chamber, the fluid communication pathway defined by asurrounding sidewall of the housing.
 2. The blood testing apparatus inaccordance with claim 1, further comprising an introducer coupled withthe housing for the introduction of the catheter or the needle into thevein or artery of the patient, the introducer being in fluidcommunication with the flash chamber.
 3. The blood testing apparatus inaccordance with claim 1, further comprising a separation membraneinterposed in the fluid communication pathway between the flash chamberand the substrate, the separation membrane being configured to allowonly blood plasma from the portion of blood to pass through the fluidcommunication pathway.
 4. The blood testing apparatus in accordance withclaim 1, further comprising a microporous membrane positioned at leastpartially within the flash chamber.
 5. The blood testing apparatus inaccordance with claim 4, wherein the microporous membrane is connectedwith the substrate.
 6. The blood testing apparatus in accordance withclaim 4, wherein the microporous membrane enables sequestration of theportion of blood in the flash chamber for a period of time.
 7. Anapparatus for testing a presence or threshold level of a substance in apatient's blood, the apparatus comprising: a needle or catheter forinsertion into a vein or artery of a patient to convey blood from thepatient, a housing having an input in fluid communication with theneedle and an output, the housing defining a flash chamber connectedwith the input for fluid communication with the needle or catheter, thehousing having at least one sidewall for viewing blood being conveyedfrom the patient; and a substrate at least partially within the housing,the substrate being configured to generate, upon contact with a portionof the blood in the flash chamber from the needle or catheter, avisually discernable reaction to the presence or the threshold level ofthe substance in the blood.
 8. The apparatus in accordance with claim 7,wherein the flash chamber is further configured to hold the portion ofthe blood.
 9. The apparatus in accordance with claim 7, furthercomprising a separation membrane interposed in a fluid communicationpathway between the flash chamber and the substrate.
 10. The apparatusin accordance with claim 7, further comprising an introducer coupledwith the housing for the introduction of the needle or the catheter intothe vein or artery of the patient.
 11. The apparatus in accordance withclaim 7, further comprising a microporous membrane positioned at leastpartially within the flash chamber.
 12. The apparatus in accordance withclaim 11, wherein the microporous membrane is connected with thesubstrate.
 13. The apparatus in accordance with claim 11, wherein themicroporous membrane enables sequestration of the portion of blood inthe flash chamber for a period of time.
 14. The apparatus in accordancewith claim 11, wherein the microporous membrane includes a clottingfactor to clot at least some of the portion of blood.
 15. An apparatusfor testing a presence or threshold level of a substance in a patient'sblood conveyed via a needle or catheter introduced into a vein or arteryof the patient, the apparatus comprising: a housing having an inputconfigured for fluid communication with the needle or catheter, anoutput, and a flash chamber connected with the input and configured toreceive a portion of the blood conveyed via the needle or the catheter,the housing having at least one sidewall for viewing at least some ofthe portion of the blood being conveyed from the patient; and asubstrate at least partially within the housing, the substrate beingconfigured to generate, upon contact with a portion of the blood in theflash chamber from the needle or catheter, a visually discernablereaction to the presence or the threshold level of the substance in theblood.